EFFECT OF LOW-DOSE RAMIPRIL ON MICROALBUMINURIA IN NORMOTENSIVE OR MILD HYPERTENSIVE NON-INSULIN-DEPENDENT DIABETIC-PATIENTS

Microalbuminuria predicts early mortality and renal disease in non-ins ulin-dependent diabetic patients. In insulin-dependent diabetic patien ts, angiotensin converting enzyme inhibition decreases microalbuminuri a and retards the progression of renal disease. The aim of this study was to evaluate the effect of low dose ramipril on albumin excretion r ate (AER) and blood pressure in non-insulin-dependent diabetic patient s with persistent microalbuminuria (AER > 20 < 200 mu g/min) and norma l blood pressure or mild hypertension. The study was a randomized, dou ble-blind, placebo-controlled clinical trial of 6 months duration at 1 4 hospital-based diabetes centers in northeastern Italy. Blood pressur e, plasma glucose, and body weight were determined every month; AER, s erum creatinine, glycosylated hemoglobin, and plasma lipids at baselin e, after 1 month, and at the end of the study. Of 122 non-insulin-depe ndent diabetic patients randomly allocated in blocks of four to receiv e either ramipril (1.25 mg/day) or placebo, 108 (54 in the ramipril gr oup and 54 in the placebo group) completed the study. At baseline, age , duration of diabetes, body mass index, and glycosylated hemoglobin w ere similar in the two groups and remained unchanged throughout the st udy. In the placebo group, AER rose from a baseline median of 65 mu g/ min (range 53 to 76, 95% confidence Interval) to 72 mu g/min (57 to 87 ) and to 83 mu g/min (62 to 104) after 1 and 6 months, respectively, b ut fell from 62 mu g/min (48 to 76) to 45 mu g/min (33 to 57) and to 5 3 mu g/min (38 to 69), respectively, in the ramipril group, a signific ant difference between the groups (P < .01). Blood pressure was simila r in the two groups at baseline and only systolic blood pressure was l ower in the ramipril group at several time points during the study. In conclusion, low-dose angiotensin converting enzyme inhibition with ra mipril can arrest the progressive rise in albuminuria in non-insulin-d ependent diabetic patients with persistent microalbuminuria.